Cydectin. Fort Dodge PRODUCT DESCRIPTION

Transcription

1 Cydectin Fort Dodge moxidectin Injectable Solution for Beef and Nonlactating Dairy Cattle Antiparasitic Contains 10 mg moxidectin/ml Not for use in female dairy cattle of breeding age, veal calves, and calves less than 8 weeks of age. For Treatment of Infections and Infestations Due to Internal and External Parasites of Cattle NADA , Approved by FDA Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. PRODUCT DESCRIPTION CYDECTIN Injectable Solution is a ready-to-use, sterile solution containing 1% moxidectin. Moxidectin is an endectocide in the milbemycin chemical class which shares the distinctive mode of action characteristic of macrocyclic lactones. CYDECTIN Injectable is specially formulated to allow moxidectin to be absorbed from the site of injection and distributed internally to the areas of the body affected by endo- and/or ectoparasitism. Moxidectin binds selectively and with high affinity to glutamate-gated chloride ion channels which are critical to the function of invertebrate nerve and muscle cells. This interferes with neurotransmission resulting in paralysis and elimination of the parasite. INDICATIONS CYDECTIN Injectable, when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle: Gastrointestinal Roundworms Ostertagia ostertagi Adults and Inhibited L4 Haemonchus placei Adults Trichostrongylus axei Adults Trichostrongylus colubriformis L4 Cooperia oncophora Adults Cooperia punctata Adults and L4 Cooperia surnabada Adults and L4 Oesophagostomum radiatum Adults and L4 Trichuris spp. Adults

2 Lungworms Dictyocaulus viviparus Adults and L4 Cattle Grubs Hypoderma bovis Hypoderma lineatum Mites Psoroptes ovis (Psoroptes communis var. bovis) Lice Linognathus vituli Solenopotes capillatus Persistent Activity: CYDECTIN Injectable has been proven to effectively protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, Haemonchus placei for 35 days after treatment, and Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment. Management Considerations for External Parasites: For most effective external parasite control, CYDECTIN Injectable should be administered to all cattle in the herd. Cattle entering the herd following this administration should be treated prior to introduction. Consult your veterinarian or a livestock entomologist for the most appropriate time to apply CYDECTIN Injectable in your location to effectively control external parasites. DOSAGE The recommended rate of administration for CYDECTIN Injectable is 1 ml for each 110 lb (50 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of injectable which must be administered based on the weight of animal being treated. Be careful not to overdose animals; estimate animal s body weight as closely as possible or weigh animals individually. Weight (lb) Weight (kg) Dose (ml) ADMINISTRATION CYDECTIN Injectable should be administered by subcutaneous injection under the loose skin in front of or behind the shoulder (Figure 1). Needles 1/2 to 3/4 inch in

3 length and 16 to 18 gauge are recommended for subcutaneous injections. Use sterile, dry equipment and aseptic procedures when withdrawing and administering CYDECTIN. Figure 1. Sites for administration of CYDECTIN Injectable HUMAN WARNINGS Not For Use in Humans. Keep this and all drugs out of the reach of children. The material safety data sheet (MSDS) provides more detailed occupational safety information. A copy of the MSDS can be obtained by calling To report adverse reactions attributable to exposure to this product, call RESIDUE WARNINGS Cattle must not be slaughtered for human consumption within 21 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal. RESIDUE WARNINGS Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. NAC No.: ANIMAL SAFETY WARNINGS Do not use in sick, debilitated, or underweight animals. In foreign countries there have been reports of adverse effects, including death. This product should not be used in calves less than 8 weeks of age because safety testing has not been done in the U.S. in calves less than 8 weeks of age. ENVIRONMENTAL WARNINGS Studies indicate that when moxidectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive. Free moxidectin may adversely affect fish and certain aquatic organisms. Do not contaminate water by direct application or by improper disposal of drug containers. PRECAUTIONS CYDECTIN Injectable has been formulated specifically for subcutaneous injection

4 in cattle and should not be given by other routes of administration. Subcutaneous injection can cause transient local tissue reaction that may result in trim loss of edible tissue at slaughter if animals are slaughtered within 35 days after treatment. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result. CYDECTIN Injectable is effective against the migrating stage of cattle grubs (Hypoderma larvae). Treatment with CYDECTIN Injectable during the period when grubs are migrating through vital areas may cause undesirable host-parasite reactions. Killing H. lineatum when they are located in peri-esophageal tissues may cause bloat. Killing H. bovis when they are in the vertebral canal may cause staggering or hindlimb paralysis. Cattle should be treated as soon as possible after heel fly (warble fly) season to avoid this potential problem. Cattle treated with CYDECTIN Injectable at the end of fly season can be retreated during the winter without danger of grub-related reactions. Consult you veterinarian for more information regarding these secondary grub reactions and the correct time to treat with CYDECTIN Injectable. ANIMAL SAFETY U.S. tolerance and toxicity studies have demonstrated that CYDECTIN Injectable has an adequate margin of safety for use in cattle 8 weeks of age and older. No toxic signs were seen in growing cattle given up to 5 times the recommended dose. Calves as young as 8 weeks of age showed no toxic signs when treated with up to 3 times the recommended dose while nursing from cows concurrently treated with the recommended dose level of CYDECTIN Injectable. Mild, transient ataxia was noted in growing cattle receiving 10 times the recommended dose and in bulls treated at 4.5 times the recommended dose. In breeding animals (bulls and cows in estrous and during early, mid and late pregnancy), treatment with at least 3 times the recommended dose had no effect on breeding performance. Signs of toxicity include ataxia, excessive salivation, depression, and mydriasis. These signs usually occur within 12 to 48 hours post-treatment. STORAGE Store product at or below 77 F (25 C). Protect from light. DISPOSAL Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration. PACKAGE INFORMATION CYDECTIN Injectable is available in 200 ml and 500 ml polyethylene bottles.

5 2003 Fort Dodge Animal Health. All Rights Reserved. U.S. Patent Nos. 4,916,154 and 5,965,603 Fort Dodge Animal Health Fort Dodge, Iowa USA New April A FORT DODGE ANIMAL HEALTH Division of Wyeth 800 5TH STREET N.W., P.O. BOX 518, FORT DODGE, IA, Telephone: Fax: Website: Disclaimer Every effort has been made by Jeffers to ensure the accuracy of the information listed above. However, it remains your responsibility to become familiar with the products you are purchasing. Please consult your family veterinarian if you have any questions.

Date of Approval: FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION LONGRANGE (eprinomectin) Extended-Release Injectable Parasiticide for the treatment and control of internal and external

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